Status:
COMPLETED
Congenital and Neonatal Malaria in Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
Brief Summary
This study will look at blood samples taken from 300 preterm babies and newborns admitted for inpatient care at Hopital Gabriel Toure in Bamako, Mali, and to gather information that will help the inve...
Detailed Description
The purpose of this cross-sectional study is to determine the rate of congenital and acquired malaria in inpatient neonates at a tertiary pediatric hospital in Bamako, Mali. The primary study endpoint...
Eligibility Criteria
Inclusion
- Neonates: 1) Preterm born before 37 weeks of pregnancy admitted for inpatient care at HGT or Neonates aged between 0 - 28 days admitted for inpatient care at HGT 2) Admission weight more than 2000 grams 3) Parental informed consent obtained and signed for infant participation Criteria for Mothers: - Consenting mother of an enrolled infant
Exclusion
- Neonates: 1) Outpatient infant 2) Infant weighing less than 2000g 3) Infants presenting the following symptoms of critical condition: bradycardy, gasp, severely altered general condition 4) Presence of severe anemia 5) Infants who are judged by the study physicians to be unfit for enrollment for any reason 6) Informed consent denied Criteria for Mothers: 1) Mothers with severe malaria (2) 2) Mothers with an acute severe disease 3) Mothers who are judged by the study physician to be unfit for enrollment for any reason 4) Informed consent denied
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00384267
Start Date
October 1 2006
End Date
April 1 2009
Last Update
November 11 2011
Active Locations (1)
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1
Hopital Gabriel Toure
Bamako, Mali